Randomized, Open-Label, Multiple-Dose Study to Evaluate the Effect of Famotidine on the Pharmacokinetics of Atazanavir/Ritonavir/Tenofovir in Healthy Subjects
Overview
- Phase
- Phase 1
- Intervention
- Atazanavir+Ritonavir+Tenofovir
- Conditions
- HIV Infections
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir, identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with famotidine results in atazanavir exposures similar to those when atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy subjects.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and female subjects between the ages 18 to 50 years old with a BMI 18 to 32 kg/m2
Exclusion Criteria
- Not provided
Arms & Interventions
A
Intervention: Atazanavir+Ritonavir+Tenofovir
B
Intervention: Atazanavir+Ritonavir+Tenofovir+Famotidine
C
Intervention: Atazanavir+Ritonavir+Tenofovir+Famotidine
D
Intervention: Atazanavir+Ritonavir+Tenofovir+Famotidine
E
Intervention: Atazanavir+Ritonavir+Tenofovir+Famotidine
Outcomes
Primary Outcomes
Assess PK of ATV, identifying dosing regimens of ATV/RTV/TDF when dosed with FAM that result in ATV exposures similar to ATV/RTV/TDF 300/100/300 mg with and without FAM.
Secondary Outcomes
- Assess PK , safety, and tolerability of ATV/RTV/TDF with and without FAM.